Shockwave catheter capable of crossing high‑resistance lesion

Abstract

A forward shockwave device, comprising inner electrodes and an outer electrode, and wires connected to the electrodes. The electrodes are arranged to form spark gaps therebetween. In response to a high potential difference applied across the wires, an arc discharge is generated across the spark gaps, and shockwaves propagate forward in a distal direction from the spark gaps through a conductive fluid in the spark gaps. Also disclosed is a forward shockwave catheter comprising the forward shockwave device. The forward shockwave catheter comprising the forward shockwave device reduces, during surgeries for treating high-resistance lesions in human conduit systems such as blood vessels, the operation steps for change into rotational atherectomy due to the inability of conventional shockwave balloons to be in place, thereby simplifying surgical processes and improving the treatment efficiency.

Description

A shockwave catheter for penetrating high-resistance lesions Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a forward-penetrating shock wave device for high-resistance lesions and a forward-penetrating shock wave catheter containing the shock wave device. Background Technology

[0002] A catheter is a medical device that can be inserted into the body to treat diseases or perform medical procedures. For example, a patient may have atherosclerosis, which causes narrowing of blood vessels. Atherosclerosis is usually treated with angioplasty. In angioplasty, a balloon is inserted through a catheter into the narrowed blood vessel due to the disease and inflated to dilate the vessel, while a stent is inserted through a catheter into the lesion site and inflated to provide expansion and support, ultimately restoring forward blood flow to the coronary arteries.

[0003] The challenges posed by high-resistance coronary artery lesions (calcified lesions) are currently far greater than imagined. The difficulty with calcified lesions often lies not in the guidewire reaching the distal vessel through the lesion, but in the inability of devices such as balloons and stents to be effectively positioned and inflated after the guidewire is in place via catheter. Current treatments for calcified lesions include high-pressure balloon dilation, rotational atherectomy (RA), and intravascular lithotripsy (IVL). The rapid development of IVL technology in recent years is primarily reflected in the advancement of shockwave balloon devices. For example, patent document CN112842460A discloses a shockwave generating system with hydraulic monitoring and supply for cardiovascular stenosis. This system includes a liquid medium, a hydraulic sensor, a shockwave generator, an operating handle, a catheter, and a balloon, with an electrode pair disposed inside the balloon. Patent document CN113332570A discloses a balloon catheter and shockwave generating system, including a catheter body, a balloon connected to the distal end of the catheter body, and electrode devices. Patent document CN115192122A discloses a shockwave balloon catheter device, including a catheter body and a balloon, with the balloon connected to the distal end of the catheter body. The catheter body has an extension along its own axial direction. The patent document CN114916992A discloses a pressure wave balloon catheter with integrated pulsed focused ultrasound; the patent document CN117297713A discloses a directional shock wave balloon catheter, including a balloon and a tube body, with the proximal end of the balloon communicating with the distal end of the tube body, the balloon having a chamber, the tube body having a channel communicating with the chamber, and also including an electrode assembly, an elastomer, and a control magnet disposed outside the balloon; the patent document CN118203389A discloses a shock wave balloon and a shock wave balloon assembly, the shock wave balloon including a first balloon and a second balloon, the second balloon having a shock wave emitting element disposed inside for releasing radial shock waves along the radial direction of the second balloon.

[0004] High-pressure balloon dilation aims to rupture calcified lesions through high pressure, but its effectiveness is often limited because the hardness and thickness of the calcified lesions may exceed the balloon's capacity. Rotational atherectomy, a method that removes calcified lesions using a high-speed rotating burr, is highly effective but carries a high risk of vascular injury and other complications. Shockwave balloon dilation, which uses shock waves to break up calcified lesions, has seen rapid development in recent years. Its principle involves adding a shockwave device to the catheter to help break up intravascular calcified lesions. The shockwave device generates shock waves that impact the calcified lesions around the device, breaking up the hard and brittle calcium, making it easier for the balloon catheter to dilate the vessel. The shockwave generated by this device propagates circumferentially in the vertical direction around the catheter (forming a near-cylindrical surface), with better results when the lesion surrounds the device. However, this requires the balloon to be placed within the calcified lesion after the guidewire has been inserted for shockwave manipulation. In some cases, however, the vascular lesion is heavily burdened (e.g., with an extremely thick calcified cap), making the lesion too narrow or too hard, preventing the balloon catheter and shockwave device from passing through. Balloon catheters and shock wave devices can only reach the entrance of tightly packed and difficult-to-penetrate lesions. In this case, if the shock wave device only releases a longitudinal shock wave perpendicular to the long axis of the balloon catheter at the lesion entrance, it will be ineffective in breaking up lesions located at its tip (such as calcified caps). Summary of the Invention

[0005] To address the aforementioned shortcomings of existing shockwave devices, such as those comprising balloons and catheters, we have, based on extensive clinical surgical practice and postoperative follow-up results, and considering that catheters have a smaller diameter than balloons and are easier to pass through lesion areas, devised a catheter-based shockwave system that releases shockwave energy forward along the long axis of the catheter, replacing the longitudinal (perpendicular to the long axis of the balloon-catheter) release of shockwave energy. This provides a "tunneling" shockwave device and a shockwave catheter incorporating this novel device, distinct from existing technologies. During surgical procedures, it can generate forward shockwaves to tunnel forward after shattering the cap of a high-resistance lesion (such as a calcified cap). Therefore, this invention provides the following technical solution.

[0006] A shock wave device comprising:

[0007] An inner electrode, the inner electrode being arranged around a longitudinal axis and extending axially along the longitudinal axis;

[0008] An outer electrode, which is arranged around the inner electrode and radially away from the inner electrode, and extends axially along the longitudinal axis;

[0009] A first wire, which is electrically connected to the inner electrode and electrically insulated from the outer electrode;

[0010] The second wire is electrically connected to the outer electrode and electrically insulated from the inner electrode;

[0011] And a spark gap, which is formed between the uninsulated portion of the inner electrode and the uninsulated portion of the outer electrode;

[0012] In response to the potential difference applied across the first and second conductors, an arc discharge is generated across the spark gap, causing the arc discharge to generate a single shock wave, which propagates forward from the spark gap through the conductive fluid in the spark gap in a distance direction.

[0013] Preferably, the shock wave device further includes one or more peripheral cavities located between the inner electrode and the outer electrode, wherein the peripheral cavities may be filled with a conductive fluid.

[0014] Furthermore, the aforementioned shock wave device also includes an outer insulating layer located between the inner electrode and the outer electrode, which serves to insulate the outer electrode from the first wire and the inner electrode from the second wire.

[0015] In one embodiment, the outer insulation layer comprises a polymer, adhesive, or plastic insert.

[0016] The uninsulated portion of the external electrode is formed at the distal end of the external electrode, and the uninsulated portion of the internal electrode is formed at the distal end of the internal electrode.

[0017] The distal portion of the aforementioned inner electrode is axially misaligned with the distal portion of the outer electrode; or

[0018] The distal portion of the inner electrode is aligned with the distal portion of the outer electrode.

[0019] Preferably, the uninsulated portions of the inner electrode and the outer electrode include chamfered distal ends.

[0020] Furthermore, the inner electrode and the outer electrode include an insulating coating for insulating the outer electrode from the first wire and for insulating the inner electrode from the second wire. The insulating coating includes holes that form uninsulated portions of the electrodes and form the spark gap.

[0021] In a preferred embodiment, the aforementioned internal electrode comprises two, namely a first internal electrode and a second internal electrode, thereby enabling the forward shock wave device to generate a forward dual shock wave. Correspondingly, a shock wave device containing one internal electrode can generate a forward shock wave.

[0022] That is, the present invention also provides a shock wave device, which includes:

[0023] A first inner electrode and a second inner electrode are arranged around a longitudinal axis and extend axially along the longitudinal axis, and the first inner electrode and the second inner electrode are offset from each other in the circumferential direction.

[0024] An outer electrode is arranged around the first inner electrode and the second inner electrode and is radially away from the first inner electrode and the second inner electrode, and extends axially along the longitudinal axis;

[0025] A first wire, which is electrically connected to the first inner electrode and electrically insulated from the outer electrode;

[0026] The second wire is electrically connected to the second inner electrode and electrically insulated from the outer electrode;

[0027] A first spark gap is formed between the uninsulated portion of the first inner electrode and the first uninsulated portion of the outer electrode; and

[0028] The second spark gap is formed between the uninsulated portion of the second inner electrode and the second uninsulated portion of the outer electrode;

[0029] In response to the potential difference applied across the first and second conductors, an arc discharge is generated across the first and second spark gaps, causing the arc discharge to generate a double shock wave, which propagates forward from the spark gap through the conductive fluid in the spark gap in a remote direction.

[0030] Preferably, the external electrode includes an insulating coating for insulating the external electrode from the wire. The insulating coating includes a first hole and a second hole, which respectively form the first uninsulated portion and the second uninsulated portion of the external electrode.

[0031] Furthermore, the aforementioned shock wave device also includes one or more peripheral cavities located between the outer electrode and the inner electrode, wherein the peripheral cavities may be filled with a conductive fluid.

[0032] Preferably, the above-mentioned shock wave device further includes an outer insulating layer, which is located between the outer electrode and the wire, and is used to insulate the outer electrode from the wire.

[0033] The aforementioned outer insulation layer includes polymers, adhesives, or plastic inserts.

[0034] The uninsulated portion of the external electrode is formed at the distal end of the external electrode, and the uninsulated portion of each of the internal electrodes is formed at the respective distal end of the internal electrode.

[0035] In one embodiment, the distal portions of each of the inner electrodes are axially misaligned with the distal portions of the outer electrodes; or

[0036] The distal portion of each inner electrode is aligned with the respective distal portion of the outer electrode.

[0037] Preferably, the uninsulated portions of the inner electrode and the outer electrode include chamfered distal ends.

[0038] Furthermore, each inner electrode includes an insulating coating, and each insulating coating includes a hole forming an uninsulated portion of the respective inner electrode.

[0039] A second aspect of the present invention provides a shock wave duct, comprising the shock wave device as described above, and further comprising an inner extension member and an outer extension member, wherein,

[0040] The shock wave device is disposed at the distal portion of the shock wave duct and surrounding the inner extension, the inner extension including an inner cavity along a longitudinal axis for receiving a guidewire.

[0041] The shock wave device is configured to generate a shock wave that propagates forward in a remote direction from the shock wave device.

[0042] Preferably, the shock waveguide further includes an inner insulating layer located between the inner extension and the inner electrode.

[0043] Furthermore, the aforementioned shock wave duct also includes a distal cap that attaches the inner extension and the outer extension together, the distal cap including a tapered portion for guiding the shock wave forward.

[0044] Preferably, the shockwave catheter further includes a distal tip attached to the distal portion of the distal cap and the inner extension, the distal tip including a tapered portion to facilitate movement of the shockwave catheter in the blood vessel.

[0045] In one embodiment, the distal cap is configured to contain the conductive fluid to fill one or more peripheral cavities and the spark gap of the shock wave device.

[0046] The aforementioned shockwave catheter can be used to treat vascular high-resistance lesions and urinary system lesions such as ureteral lesions.

[0047] Therefore, another aspect of the present invention provides a method for treating vascular high-resistance lesions (e.g., calcified plaques), comprising the following steps:

[0048] A shockwave catheter is inserted into a patient's blood vessel, the shockwave catheter including the shockwave device described above;

[0049] The shockwave catheter is advanced forward into the blood vessel in a remote direction until the distal portion of the shockwave device is opposite the proximal (or initiation) portion of the treatment site.

[0050] A potential difference is applied across the first and second conductors;

[0051] A shock wave is generated at the spark gap in response to the applied potential difference;

[0052] The shock wave propagates forward in a distance from the spark gap through the conductive fluid within the spark gap; and

[0053] The shock wave is used to impact the high-resistance vascular lesion (such as calcified plaque), thereby pulverizing the lesion at the treatment site and treating the vascular plaque or high-resistance lesion.

[0054] Furthermore, the above method also includes the following steps:

[0055] Remove the shock wave catheter from the blood vessel;

[0056] Insert the second medical device into the blood vessel;

[0057] The second medical device is advanced into the blood vessel in a remote direction to continue treatment of vascular plaque or high-resistance lesions at the treatment site.

[0058] Furthermore, the second medical device includes a balloon catheter and a stent, thereby enabling its use in conjunction with the forward shockwave catheter of the present invention.

[0059] The forward shockwave device and catheter containing the device provided by this invention can generate forward shock waves during surgical procedures for treating high-resistance vascular lesions (such as calcified plaques) to break up the cap of the lesion and advance forward. It has forward-digging capability in high-resistance calcified lesions comparable to that of a rotary burr, while also possessing the safety of a shockwave balloon. The shockwave device and catheter do not require a balloon. This simple catheter design allows for access to the lesion origin with a smaller size (compared to a balloon) and effective digging within the lesion using shock waves. Therefore, this is more convenient and faster to use during surgery, saving valuable surgical time and reducing surgical risks and medical accidents. In summary, such a device and approach can not only effectively treat thick calcified lesions but also reduce the risk of vascular damage, improving the safety and effectiveness of treatment. Attached Figure Description

[0060] Figure 1 is a schematic diagram of an embodiment of the forward shock wave duct including a forward shock wave device according to the present invention.

[0061] Figure 2 is a longitudinal cross-sectional view of the forward shock waveguide embodiment shown in Figure 1.

[0062] Figure 3 is a structural schematic diagram of an embodiment of the dual shock wave device of the present invention.

[0063] Figure 4 is a cross-sectional schematic diagram of an embodiment of the dual shock wave device shown in Figure 3.

[0064] Figure 5 is a structural schematic diagram of an embodiment of the forward shock wave duct of the present invention, which includes a dual shock wave device.

[0065] Figure 6 is another structural schematic diagram of the dual shock waveguide embodiment shown in Figure 5.

[0066] Figure 7 is another structural schematic diagram of the dual shock waveguide embodiment shown in Figure 5.

[0067] Figure 8 is a structural schematic diagram of an embodiment of the single shock wave device of the present invention.

[0068] Figure 9 is a schematic diagram of another embodiment of the single shock wave device of the present invention.

[0069] Figure 10 is a schematic diagram of a forward shock wave duct embodiment of the present invention, which includes a single shock wave device.

[0070] Figure 11 is another structural schematic diagram of the single shock waveguide embodiment shown in Figure 10.

[0071] Figure 12 is another structural schematic diagram of the single shock waveguide embodiment shown in Figure 10.

[0072] Figure 13 is another structural schematic diagram of the single shock waveguide embodiment shown in Figure 10.

[0073] Figures 14 and 15 are surgical schematic diagrams of the shockwave catheter of the present invention used to treat vascular high-resistance lesions (such as calcified plaques).

[0074] Figure 16 is a flowchart illustrating the method of treating high-resistance vascular lesions (such as calcified plaques) using a dual shockwave catheter.

[0075] Figure 17 is a flowchart illustrating the method of treating high-resistance vascular lesions (such as calcified plaques) using a single shockwave catheter. Detailed Implementation

[0076] Traditional shockwave balloons generate shock waves that propagate circumferentially in the vertical direction around the catheter (forming a near-cylindrical surface), requiring the balloon to be located within the calcified lesion. However, if the lesion's entry point is extremely narrow and rigid (high-resistance lesion), the shockwave balloon cannot penetrate the lesion, preventing subsequent treatment from being initiated. The tunneling shockwave / shockwave device of this invention generates forward shock waves, enabling more effective treatment of high-resistance calcified lesions, especially those with extremely high opening resistance (such as lesions with very thick calcification caps). Its ability to break up high-resistance (or calcified) lesions with forward impact allows it to continue tunneling forward after breaking the lesion opening, and its relatively small diameter also facilitates its forward advancement until the entire lesion is cleared. This allows subsequent balloon or stent treatments to be successfully placed and effective.

[0077] The forward-facing shockwave device possesses highly efficient tunneling capabilities. While maintaining the safety of existing shockwave balloons, it provides tunneling capabilities comparable to rotary atherectomy heads, reducing the risk of vascular damage and embolism caused by rotary atherectomy. The forward-facing shockwave device of this invention also reduces the need to switch to rotary atherectomy during surgery when traditional shockwave balloons cannot reach the target area, thereby lowering the risk of complications. Furthermore, the tunneling-type forward-facing shockwave device of this invention simplifies the surgical procedure and improves treatment efficiency.

[0078] In terms of working principle, this invention changes the direction of shock wave / shock wave energy release in existing shock wave / shock wave surgical devices with the same function used in similar "vascular unblocking" surgeries. Structurally, the forward shock wave device of this invention includes inner and outer electrodes, and wires connected to the electrodes. The electrodes are arranged to form a spark gap between them. In response to a high potential difference applied across the wires, an arc discharge is generated across the spark gap, and the shock wave propagates forward from the spark gap through the conductive fluid in the spark gap in a remote direction. The structure of this invention eliminates the need for a balloon, resulting in a smaller device diameter, easier passage, and no hindrance to subsequent high-pressure, cutting balloon expansion. This makes the surgical operation more convenient and faster, significantly saving valuable surgical time, thereby reducing surgical risks and the occurrence of medical accidents.

[0079] In addition, the shockwave device and shockwave device of the present invention can be used not only for vascular "unblocking" surgery, such as surgery to treat vascular high resistance diseases (e.g., calcified plaques), but also for surgical treatment of other diseased organs, such as the urinary system, such as the ureter, for "obstructive" diseases, such as the removal of stones in the ureter.

[0080] For ease of description, the forward shock wave device / forward shock wave duct can be referred to as shock wave device / shock wave duct respectively in this article, and collectively referred to as "shock wave system".

[0081] This invention provides two types of forward shock wave devices and forward shock wave ducts. One type uses one internal electrode and can generate a single (one) shock wave / vibration wave; the other type uses two internal electrodes and can generate a dual shock wave / vibration wave.

[0082] For ease of description, the forward shock wave device / shock wave duct used to generate dual shock waves will be referred to as "dual shock wave device / dual shock wave duct" in this article, and collectively referred to as "dual shock wave system". Correspondingly, the forward shock wave device / shock wave duct used to generate single (one) shock waves will be referred to as "single (one) shock wave device / single (one) shock wave duct", and collectively referred to as "single (one) shock wave system".

[0083] Comparatively, dual shock waves have certain advantages over single shock waves in some aspects. For example, some advantages of dual shock wave systems compared to single shock wave systems include, but are not limited to:

[0084] 1. Improve the efficiency of calcification and crushing.

[0085] Increased sound pressure through pulse stacking: The dual-shock wave device utilizes two pairs of electrodes to generate two overlapping sound pressure fields. This overlap significantly increases the effective sound pressure at calcified sites. The result is more efficient and uniform fragmentation of calcium deposits. This synergistic effect between the dual shock waves can achieve higher peak pressures, thus more effectively mechanically disrupting calcified plaques.

[0086] Crack propagation: Dual shock waves can create multiple crack initiation points within calcified plaques. This enhances crack propagation within the plaque, leading to more thorough fragmentation. This is particularly advantageous for treating thicker calcified plaques. A single shock wave typically only produces surface cracks and cannot break up deep calcified plaques.

[0087] 2. Improves energy distribution and reduces the risk of vascular damage.

[0088] More uniform energy distribution: Dual shock waves can make the energy distribution on the entire lesion more uniform.

[0089] Reduced risk of thermal injury: The dual-shock wave method improves energy transfer efficiency, reducing the need for excessive energy and thus lowering the risk of thermal injury. This is especially important in patients with fragile blood vessels.

[0090] The two types of shock waves can be summarized as follows:

[0091]

[0092] Through the following detailed description of embodiments, which are merely illustrative of non-limiting examples, and the accompanying drawings, those skilled in the art will gain a clearer understanding of the various features and advantages of the present invention.

[0093] For the sake of brevity and clarity, the description of embodiments, with reference to the accompanying drawings, pertains to forward shock wave devices and shock wave ducts including such forward shock wave devices. Although parts of the invention will be described in conjunction with the embodiments provided herein, it should be understood that these embodiments are not intended to limit the invention to these embodiments. Rather, the invention is intended to cover alternatives, modifications, and equivalents to the embodiments described herein, which are included within the scope of the invention as defined by the appended claims. Furthermore, specific details are set forth in the following detailed description to provide a thorough understanding of the invention. However, those skilled in the art, i.e., those of ordinary skill, will recognize that the invention can be practiced without these specific details, and / or using a plurality of details resulting from combinations of features according to particular embodiments. In many instances, well-known systems, methods, procedures, and components have not been described in detail to avoid unnecessarily hindering the understanding of the features of the embodiments of the invention.

[0094] In embodiments of the present invention, the description of a given element or the use of a specific element number in a particular figure or a reference in a corresponding description section may cover the same, equivalent or similar element or element number mentioned in another figure or its associated description section.

[0095] References to "embodiment / example," "another embodiment / example," "some embodiments / examples," "some other embodiments / examples," etc., indicate that the described embodiments / examples may include specific features, structures, characteristics, attributes, elements, or limitations, but not every embodiment / example necessarily includes that specific feature, structure, characteristic, attribute, element, or limitation. Furthermore, the repeated use of the phrases "in an embodiment / example" or "in another embodiment / example" does not necessarily refer to the same embodiment / example.

[0096] The use of terms such as "comprising," "including," and "having" does not exclude the presence of other features / elements / steps not listed. Listing certain features / elements / steps in different embodiments does not imply that these features / elements / steps cannot be combined in one embodiment. The term "a" as used herein can mean one or more. The use of " / " in figures or related text is understood as "and / or" unless otherwise stated. According to known mathematical definitions, the term "set" is defined as a non-empty finite organization that includes at least one element (e.g., a set as defined herein can correspond to a cell, a single-element set, or a multi-element set). The terms "first," "second," etc., are used only as labels or identifiers and are not intended to impose numerical requirements on their related expressions. Example

[0097] Referring to Figures 1, 2, 3, and 8, this invention provides an embodiment of a forward shockwave catheter 100 including shockwave devices 200 and 300, which can be used to treat diseases and / or perform medical procedures. In particular, the forward shockwave catheter 100 can be used to treat high-resistance lesions in a patient's human ductal network system. For example, the forward shockwave catheter 100 can be used for percutaneous coronary intervention.

[0098] Arterioplasty is used to treat atherosclerosis (e.g., calcified lesions in the coronary arteries) or urinary tract diseases (e.g., kidney stones in the ureter). The forward shockwave catheter 100 includes shockwave devices 200, 300 that generate shock waves that propagate forward and distally from the forward shockwave catheter 100 to break up high-resistance lesions (such as vascular calcified plaques). More specifically, one embodiment of shockwave device 200 is configured to generate dual shock waves, namely a first shock wave and a second shock wave, and may be referred to as dual shockwave device 200, while another embodiment of shockwave device 300 is configured to generate a single shock wave and may be referred to as single shockwave device 300.

[0099] In embodiments of the invention, the forward shock wave duct 100 includes a dual shock wave device 200 for generating dual shock waves, or a single shock wave device 300 for generating a single shock wave. The forward shock wave duct 100 also includes an inner extension 110 extending along a longitudinal axis and having an inner cavity 112. The forward shock wave duct 100 further includes an outer extension 120 arranged around the shock wave devices 200 and 300 and extending along a longitudinal axis.

[0100] The following describes two types of forward shock wave devices 200 and 300, as well as an embodiment of a forward shock wave duct 100 including the forward shock wave devices 200 and 300.

[0101] Dual shock wave device 200

[0102] As shown in Figures 3 and 4, the present invention provides a dual shock wave device 200 for generating dual shock waves and a forward shock wave duct 100 including the dual shock wave device 200, wherein the dual shock waves include a first shock wave and a second shock wave.

[0103] The dual shock wave device 200 includes a first inner electrode 210 and a second inner electrode 220, which are arranged around and extend axially along a longitudinal axis, and are circumferentially offset from each other. When a forward shock wave duct 100 is used, the first inner electrode 210 and the second inner electrode 220 are arranged around an inner extension 110. For example, each of the first inner electrode 210 and the second inner electrode 220 has an arcuate profile around the inner extension 110. The dual shock wave device 200 includes an outer electrode 230, which is arranged around and radially away from the first inner electrode 210 and the second inner electrode 220, and extends axially along a longitudinal axis. Preferably, the inner electrodes 210, 220 and the outer electrode 230 are coaxial along the longitudinal axis. The radial arrangement of the inner electrodes 210, 220 and the outer electrode 230 forms an annular space 240 between the outer electrode 230 and the inner electrodes 210, 220. The inner electrodes 210, 220 and the outer electrode 230 can be made of suitable materials capable of withstanding high potential differences or voltage pulses, such as iron, nickel, steel, tungsten, etc. It is understood that the electrodes 210, 220, 230 can have various shapes and sizes, such as the shape shown in Figure 7.

[0104] The dual shock wave device 200 includes a first conductor 250 electrically connected to a first inner electrode 210 and electrically insulated from an outer electrode 230. Preferably, the first conductor 250 is electrically connected to the proximal portion 212 of the first inner electrode 210. The first conductor 250 is mostly insulated except for its distal portion 252, which is uninsulated. For example, the first conductor 250 is a copper wire with an insulating outer layer such as a polymer. For example, the copper at the uninsulated distal portion 252 of the first conductor 250 is electrically connected to the proximal portion 212 of the first inner electrode 210. It is understood that the uninsulated distal portion 252 of the first conductor 250 may be connected to other portions of the first inner electrode 210, such as the intermediate portion or a portion closer to the distal portion 214.

[0105] The dual shock wave device 200 includes a second conductor 260 electrically connected to a second inner electrode 220 and electrically insulated from an outer electrode 230. Preferably, the second conductor 260 is electrically connected to the proximal portion 222 of the second inner electrode 220. The second conductor 260 is mostly insulated except for its distal portion 262, which is uninsulated. For example, the second conductor 260 is a copper wire with an insulating outer layer such as a polymer. For example, the copper at the uninsulated distal portion 262 of the second conductor 260 is electrically connected to the proximal portion 222 of the second inner electrode 220. It is understood that the uninsulated distal portion 262 of the second conductor 260 may be connected to other portions of the second inner electrode 220, such as the intermediate portion or a portion closer to the distal portion 224.

[0106] The dual shock wave device 200 includes a first spark gap 242 formed between an uninsulated portion of the first inner electrode 210 and a first uninsulated portion of the outer electrode 230. For example, the uninsulated portion of the first inner electrode 210 includes an outer arcuate surface 216 located at the distal portion 214 of the first inner electrode 210, and the first uninsulated portion of the outer electrode 230 includes a first inner arcuate surface 236 located at the distal portion 234 of the outer electrode 230. The dual shock wave device 200 also includes a second spark gap 244 formed between an uninsulated portion of the second inner electrode 220 and a second uninsulated portion of the outer electrode 230. For example, the uninsulated portion of the second inner electrode 220 includes an outer arcuate surface 226 located at the distal portion 224 of the second inner electrode 220, and the second uninsulated portion of the outer electrode 230 includes a second inner arcuate surface 238 located at the distal portion 234 of the outer electrode 230. It is worth noting that the first spark gap 242 and the second spark gap 244 are formed within or near the annular space 240.

[0107] In use, a potential difference or voltage pulse is applied to the dual shock wave device 200 to generate dual shock waves. The potential difference or voltage pulse should be high enough to cause an arc discharge. For example, the voltage pulse can be between 100V and 10kV and can be applied for various pulse durations. In response to the high potential difference or voltage pulse applied across the first conductor 250 and the second conductor 260, an arc discharge is generated across the first spark gap 242 and the second spark gap 244, causing the arc discharge to generate dual shock waves that propagate forward toward the distal end from the spark gaps 242, 244 through the conductive fluid in the spark gaps 242, 244. Specifically, the dual shock waves include a first shock wave propagating forward toward the distal end from the first spark gap 242 and a second shock wave propagating forward toward the distal end from the second spark gap 244.

[0108] For example, an arc discharge travels from the first inner electrode 210 across the first spark gap 242 to the outer electrode 230, thereby generating a first shock wave. The arc discharge can travel between any point on the uninsulated outer arcuate surface 216 of the first inner electrode 210 and any point on the uninsulated first inner arcuate surface 236 of the outer electrode 230. The arc discharge then travels along the outer electrode 230 and from the outer electrode 230 across the second spark gap 244 to the second inner electrode 220, thereby generating a second shock wave. The arc discharge can travel between any point on the uninsulated second inner arcuate surface 238 of the outer electrode 230 and any point on the uninsulated outer arcuate surface 226 of the second inner electrode 220. Notably, the first and second shock waves are generated almost simultaneously, thus propagating dual shock waves simultaneously from the device 200.

[0109] In another example, an arc discharge travels from the second inner electrode 220 through the second spark gap 244 to the outer electrode 230, thereby generating a first shock wave. The arc discharge can propagate between any point on the uninsulated outer arcuate surface 226 of the second inner electrode 220 and any point on the uninsulated second inner arcuate surface 238 of the outer electrode 230. The arc discharge then travels along the outer electrode 230 and from the outer electrode 230 through the first spark gap 242 to the first inner electrode 210, thereby generating a second shock wave. The arc discharge can travel between any point on the uninsulated first inner arcuate surface 236 of the outer electrode 230 and any point on the uninsulated outer arcuate surface 216 of the first inner electrode 210. It is understood that the first shock wave can be generated at either the first spark gap 242 or the second spark gap 244, and similarly, the second shock wave can be generated at either the first spark gap 242 or the second spark gap 244.

[0110] Furthermore, the conductive fluid in spark gaps 242 and 244 reduces the high resistance that air would normally have in spark gaps 242 and 244, enabling arc discharge. The arc discharge forms cavitation bubbles in the conductive fluid, which rapidly expand and collapse, thereby generating a double shock wave at spark gaps 242 and 244.

[0111] The arrangement of the inner electrodes 210, 220 and the outer electrode 230 allows the dual shock waves to propagate forward from the device 200 in a remote direction, i.e., in a substantially remote direction. Specifically, spark gaps 242, 244 are disposed within an annular space 240 defined by electrodes 210, 220, 230. This annular space 240 is channel-shaped, open at the front end and closed at the rear end. The front end of the opening of the annular space 240 is remote from the spark gaps 242, 244 and is defined by the farthest ends of electrodes 210, 220, 230, for example, by the farthest end of the outer electrode 230 shown in FIG. 3. The shock wave propagating forward in the remote direction will exit after passing through the front end of the opening of the annular space 240, while the shock wave propagating backward in the proximity direction will be reflected forward from the closed rear end of the annular space 240. Therefore, the annular space 240 acts as a focusing channel to guide the shock wave toward the far end. For example, the angle of the forward-guided dual shock wave relative to the longitudinal axis is less than 45°. When used in a forward-guided shockwave catheter 100 advanced through a patient's blood vessel, the dual shockwaves propagate forward along the direction of advancement of the catheter 100, directly impacting and breaking up high-resistance lesions (such as calcified plaques) in the vessel located anterior to the catheter 100. The forward-guided dual shockwaves are more effective at breaking up high-resistance lesions (such as calcified plaques) in the vessel anterior to the catheter because most of the shockwave energy is concentrated on the target lesion.

[0112] In some instances, as shown in Figure 5, the dual shock wave device 200 includes one or more peripheral cavities 270 located between the outer electrode 230 and the inner electrodes 210, 220. The peripheral cavities 270 may be filled with a conductive fluid, such as saline, which fills the spark gaps 242, 244 to allow cavitation bubbles to eventually form and collapse, generating dual shock waves. The dual shock waves propagate forward in a generally distal direction through the conductive fluid, subsequently impacting high-resistance lesions (such as calcified plaques) anterior to the forward shock wave conduit 100.

[0113] In some instances, as shown in FIG3, the dual shock wave device 200 includes an outer insulating layer 280 located between the outer electrode 230 and the wires 250, 260 for insulating the outer electrode 230 from the wires 250, 260. The outer insulating layer 280 extends axially along the outer electrode 230 from the proximal portion 232 of the outer electrode 230. For example, the outer insulating layer 280 may be made of a polymer. For example, the outer insulating layer 280 may include an adhesive or a plastic insert. As shown in FIG3, an uninsulated portion of the outer electrode 230 may be formed at the distal portion 234 of the outer electrode 230, and uninsulated portions of the inner electrodes 210, 220 may be formed at the distal portions 214, 224 of the inner electrodes 210, 220, respectively.

[0114] In some instances, as shown in Figures 3 and 5, the distal portions 214 and 224 of the inner electrodes 210 and 220 may be aligned with the distal portion 234 of the outer electrode 230. Specifically, the distal portions 214, 224, and 234 include the farthest ends of the electrodes 210, 220, and 230, and these farthest ends terminate in the same radial plane (perpendicular to the longitudinal axis).

[0115] In some instances, as shown in Figures 4 and 6, the distal portions 214, 224 of the inner electrodes 210, 220 are axially offset relative to the distal portion 234 of the outer electrode 230. For example, the distal ends of the inner electrodes 210, 220 are located in front of the distal end of the outer electrode 230. Alternatively, the distal end of the outer electrode 230 is located in front of the distal ends of the inner electrodes 210, 220. This axial offset allows control over the position and boundaries of the spark gaps 242, 244, thereby also allowing for changes in the angle of the dual shock waves relative to the longitudinal axis.

[0116] The outer insulating layer 280 can also be similarly aligned with or axially offset from the distal portions 214, 224, 234 of the electrodes 210, 220, 230. For example, as shown in FIG5, the outer insulating layer 280 is aligned with the distal portions 214, 224 of the inner electrodes 210, 220 and the distal portion 234 of the outer electrode 230, i.e., their distal ends all terminate in the same radial plane. The uninsulated portion of the inner electrode 210 includes its distal end, and the uninsulated portion of the outer electrode 230 includes its distal end. Arc discharge will be generated across these distal ends, resulting in a double shock wave at an angle of approximately 90° relative to the longitudinal axis. In another example, as shown in FIG6, the distal end of the outer electrode 230 is located in front of the distal end of the outer insulating layer 280. This will result in a smaller angle of the double shock wave relative to the longitudinal axis, for example, 45°.

[0117] In some instances, as an alternative to or supplement to the outer insulation layer 280, the outer electrode 230 may include an insulating coating for insulating the outer electrode 230 from the wires 250, 260. The insulating coating includes a first hole and a second hole forming the first and second uninsulated portions of the outer electrode 230, respectively. Similarly, each of the first and second inner electrodes 210, 220 may include an insulating coating. Each insulating coating of the inner electrodes 210, 220 includes a hole forming the uninsulated portion of the respective inner electrode 210, 220. By arranging the holes in the insulating coating, the positions of the spark gaps 242, 244 can be varied, thereby also adjusting the angle of the dual shock waves relative to the longitudinal axis.

[0118] In the examples shown in Figures 3 and 6, spark gaps 242 and 244 are formed between the uninsulated distal portions 214, 224, and 234 of electrodes 210, 220, and 230, respectively. Specifically, the first spark gap 242 is formed between the uninsulated outer arcuate surface 216 of the first inner electrode 210 and the uninsulated first inner arcuate surface 236 of the outer electrode 230. Similarly, the second spark gap 244 is formed between the uninsulated outer arcuate surface 226 of the second inner electrode 220 and the uninsulated second inner arcuate surface 238 of the outer electrode 230. The direct facing of the respective surfaces of electrodes 210, 220, and 230 defines the boundary of the annular space 240 in which the spark gaps 242 and 244 are located, and is primarily used for forward guidance of the dual shock waves. Furthermore, the axial offset between the distal portions 214 and 224 of the inner electrodes 210 and 220 and the distal portion 234 of the outer electrode 230 adjusts the boundary of the annular space 240 and the position of the spark gaps 242 and 244, thereby also adjusting the angle of the dual shock wave relative to the longitudinal axis.

[0119] In some instances, the uninsulated portions of the inner electrodes 210, 220 and the uninsulated portions of the outer electrode 230 may include chamfered distal ends. The chamfered distal ends of electrodes 210, 220, 230 can reduce the angle and improve the forward propagation of the dual shock waves. It is understood that chamfered distal ends can be applied to various instances of the dual shock wave device 200 described herein. It is also understood that the distal ends can be modified in other ways, not limited to chamfering, or in other ways besides chamfering, such as rounding the distal ends. Figure 7 shows another example of the dual shock wave device 200 in which the inner electrodes 210, 220 and the outer electrode 230 have different configurations. For example, the shape of the outer electrode 230 in Figure 7 reduces the surface area of ​​the uninsulated distal portion 234 of the outer electrode 230, thereby increasing the intensity of the dual shock waves.

[0120] Single shock wave device 300

[0121] As shown in Figures 8 and 9, the present invention provides a single shock wave device 300 for generating a single shock wave and a shock wave duct 100 including the single shock wave device 300.

[0122] The single shock wave device 300 includes an inner electrode 310 arranged around a longitudinal axis and extending axially along the longitudinal axis. When used in a forward shock wave duct 100, the inner electrode 310 is arranged around an inner extension 110. For example, the inner electrode 310 has a circumferential arcuate profile around the inner extension 110. The single shock wave device 300 includes an outer electrode 330 arranged around the inner electrode 310 and radially away from the inner electrode 310, extending axially along the longitudinal axis. Preferably, the inner electrode 310 and the outer electrode 330 are coaxially arranged along the longitudinal axis. The radial arrangement of the inner electrode 310 and the outer electrode 330 forms an annular space between them. The inner electrode 310 and the outer electrode 330 can be made of a suitable material capable of withstanding high potential differences or voltage pulses, for example, iron, nickel, steel, tungsten, etc. It is understood that the electrodes 310, 330 can have various shapes and sizes, for example, the shape shown in FIG. 13.

[0123] The single shockwave device 300 includes a first conductor 350 electrically connected to an inner electrode 310 and electrically insulated from an outer electrode 330. Preferably, the first conductor 350 is electrically connected to the proximal portion 312 of the inner electrode 310. The first conductor 350 is mostly insulated except for its distal portion 352, which is uninsulated. For example, the first conductor 350 is a copper wire having an insulating outer layer such as a polymer. For example, the copper at the uninsulated distal portion 352 of the first conductor 350 is electrically connected to the proximal portion 312 of the inner electrode 310. It is understood that the uninsulated distal portion 352 of the first conductor 350 may be connected to other portions of the inner electrode 310, such as the intermediate portion or a portion closer to the distal portion 314.

[0124] The single-shockwave device 300 includes a second conductor 360 electrically connected to the outer electrode 330 and electrically insulated from the inner electrode 310. Preferably, the second conductor 360 is electrically connected to the proximal portion 332 of the outer electrode 330. The second conductor 360 is mostly insulated except for its distal portion 362, which is uninsulated. For example, the second conductor 360 is a copper wire with an insulating outer layer such as a polymer. For example, the copper at the uninsulated distal portion 362 of the second conductor 360 is electrically connected to the proximal portion 332 of the outer electrode 330. It is understood that the uninsulated distal portion 362 of the second conductor 360 may be connected to other portions of the outer electrode 330, such as the intermediate portion or a portion closer to the distal portion 334.

[0125] The single-shock wave device 300 includes a spark gap 340 formed between the uninsulated portion of the inner electrode 310 and the uninsulated portion of the outer electrode 330. For example, the uninsulated portion of the inner electrode 310 includes an outer circumferential surface 316 at the distal portion 314 of the inner electrode 310, and the uninsulated portion of the outer electrode 330 includes an inner circumferential surface 336 at the distal portion 334 of the outer electrode 330. Notably, the spark gap 340 is formed in or near an annular space.

[0126] In use, a high potential difference or voltage pulse is applied to the single-shock wave device 300 to generate a single shock wave. The potential difference or voltage pulse should be high enough to cause an arc discharge. For example, the voltage pulse can be between 100V and 10kV and can be applied for various pulse durations. In response to the high potential difference or voltage pulse applied across the first conductor 350 and the second conductor 360, an arc discharge is generated across the spark gap 340, causing the arc discharge to generate a single shock wave that propagates forward in a remote direction from the spark gap 340 through the conductive fluid in the spark gap 340.

[0127] For example, an arc discharge travels from the inner electrode 310 through the spark gap 340 to the outer electrode 330, thereby generating a single shock wave and propagating the single shock wave from the device 300. Alternatively, the arc discharge travels from the outer electrode 330 through the spark gap 340 to the inner electrode 310. The arc discharge can travel between any point on the uninsulated outer peripheral surface 316 of the inner electrode 310 and any point on the uninsulated inner peripheral surface 336 of the outer electrode 330.

[0128] Furthermore, the conductive fluid in the spark gap 340 reduces the high resistance that air would normally have in the spark gap 340, enabling the generation of an electric arc discharge. The electric arc discharge forms cavitation bubbles in the conductive fluid, which rapidly expand and collapse, thereby generating a single shock wave at the spark gap 340.

[0129] The arrangement of the inner electrode 310 and the outer electrode 330 allows a single shock wave to propagate forward from the device 300 in a direction that is moving away from the device, i.e., forward in a generally distant direction. Specifically, the spark gap 340 is disposed within an annular space defined by the electrodes 310 and 330. This annular space is channel-shaped, open at the front end and closed at the rear end. The front end of the opening of the annular space is away from the spark gap 340 and is surrounded by the farthest ends of the electrodes 310 and 330, as shown in Figure 9. The shock wave propagating in the distant direction will exit through the front end of the opening of the annular space, while the shock wave propagating towards the near end will be reflected forward from the closed rear end of the annular space. Therefore, the annular space acts as a focusing channel to guide the shock wave in a forward and distant direction. For example, the angle of the forward-guided single shock wave relative to the longitudinal axis is less than 45°. When used in a forward-guided shockwave catheter 100 advanced through a patient's blood vessel, a single shock wave propagates forward in the direction of advancement of the catheter 100, directly impacting and breaking up high-resistance lesions (such as calcified plaques) in the vessel located in front of the catheter 100. Forward-guided single shock waves are more effective at breaking up high-resistance lesions (such as calcified plaques) in front of the catheter because most of the shock wave energy is concentrated on the plaque.

[0130] In some examples as shown in Figures 11 and 12, the single-shock wave device 300 includes one or more peripheral cavities 370 located between the outer electrode 330 and the inner electrode 310. The peripheral cavities 370 may be filled with a conductive fluid, such as saline, which fills the spark gap 340 to form and eventually collapse cavitation bubbles, thereby generating a single shock wave. The single shock wave propagates forward through the conductive fluid in a generally distant direction and subsequently impacts a high-resistance vascular lesion (such as a calcified plaque) located anterior to the forward shock wave catheter 100.

[0131] In some examples shown in Figure 8, the single shock wave device 300 includes an outer insulating layer 380 located between the inner electrode 310 and the outer electrode 330 for insulating the outer electrode 330 from the first conductor 350 and the inner electrode 310 from the second conductor 360. The outer insulating layer 380 extends axially along the outer electrode 330, starting from the proximal portion 332. For example, the outer insulating layer 380 may be made of a polymer. For example, the outer insulating layer 380 may include an adhesive or a plastic insert. As shown in Figures 8 and 10, an uninsulated portion of the outer electrode 330 may be formed at the distal portion 334 of the outer electrode 330, and an uninsulated portion of the inner electrode 310 may be formed at the distal portion 314 of the inner electrode 310.

[0132] In some examples shown in Figures 8 and 11, the distal portion 314 of the inner electrode 310 may be aligned with the distal portion 334 of the outer electrode 330. Specifically, the distal portions 314, 334 include the farthest ends of the electrodes 310, 330, which terminate in the same radial plane (perpendicular to the longitudinal axis).

[0133] In some examples shown in Figure 10, the distal portion 314 of the inner electrode 310 is axially offset relative to the distal portion 334 of the outer electrode 330. For example, the distal end of the inner electrode 310 is located in front of the distal end of the outer electrode 330. Alternatively, the distal end of the outer electrode 330 is located in front of the distal end of the inner electrode 310. This axial offset brings the uninsulated circumferential surfaces 316, 336 of the electrodes 310, 330 directly opposite each other, thereby defining the boundary of the annular space containing the spark gap 340 and primarily serving the forward propagation of the single shock wave. The axial offset thus allows control over the position and boundaries of the spark gap 340, thereby also altering the angle of the single shock wave relative to the longitudinal axis.

[0134] The outer insulating layer 380 can also be similarly aligned with or axially offset from the distal portions 314, 334 of the electrodes 310, 330. For example, as shown in FIG11, the outer insulating layer 380 is aligned with the distal portions 314, 334 of the electrodes 310, 330, i.e., their distal ends all terminate in the same radial plane. The uninsulated portions of the electrodes 310, 330 include their distal ends. An arc discharge will be generated across the distal ends, resulting in a single shock wave at an angle of approximately 90° relative to the longitudinal axis. In another example, as shown in FIG10, the distal end of the outer electrode 330 is located in front of the distal end of the outer insulating layer 380. This will result in a smaller angle of the single shock wave relative to the longitudinal axis, for example, 45°.

[0135] In some examples shown in Figure 9, as an alternative to or supplement to the outer insulating layer 380, the inner electrode 310 and the outer electrode 330 may include an insulating coating 390 for insulating the outer electrode 330 from the first conductor 350 and the inner electrode 310 from the second conductor 360. The insulating coating 390 includes holes for forming uninsulated portions of the electrodes 310 and 330 and for forming a spark gap 340. Specifically, the spark gap 340 is formed between the uninsulated outer circumferential surface 316 of the inner electrode 310 and the uninsulated circumferential surface 336 of the outer electrode 330. The direct facing of the circumferential surfaces 316 and 336 of the electrodes 310 and 330 defines the boundary of the annular space containing the spark gap 340 and facilitates the forward propagation of a single shock wave. The position of the spark gap 340 can be changed by arranging the holes in the insulating coating 390, thereby also adjusting the angle of the single shock wave relative to the longitudinal axis. For example, moving the hole forward in a direction away from the viewpoint will increase the angle, while moving it backward in a direction closer to the viewpoint will decrease the angle.

[0136] In some examples shown in Figures 8 and 12, the uninsulated portions of the inner electrode 310 and the outer electrode 330 may include chamfered distal ends. The chamfered distal ends of electrodes 310 and 330 can reduce the angle and improve the forward propagation of the single shock wave. It is understood that chamfered distal ends can be applied to various examples of the single shock wave device 300 described herein. It is also understood that the distal ends can be modified in other ways, not limited to chamfering, or modified in other forms besides chamfering, such as rounding. Figure 13 shows another example of the single shock wave device 300 in which the inner electrode 310 and the outer electrode 330 have different configurations. For example, the shape of the outer electrode 330 in Figure 13 reduces the uninsulated surface area of ​​the outer electrode 330, thereby increasing the intensity of the single shock wave.

[0137] Forward shock wave duct 100

[0138] As shown in Figures 1 and 2, the forward shock wave duct 100 may include a dual shock wave device 200 for generating dual shock waves, or the forward shock wave duct 100 may include a single shock wave device 300 for generating a single shock wave. The forward shock wave duct 100 includes an inner extension 110 with an inner lumen 112 for receiving a guidewire 160. The shock wave devices 200, 300 are arranged around the inner extension 110. For example, the inner electrodes 210, 220, 230 are arranged coaxially with the longitudinal axis.

[0139] The inner extension 110 can be braided, non-braided, or coiled. For example, the inner extension 110 can be braided to improve mechanical strength and reduce kinking. The inner extension 110 may include an insulating outer layer to insulate against the inner electrodes 210, 220, 310. Alternatively or additionally, the forward shockwave catheter 100 may include an inner insulating layer 130 located between the inner extension 110 and the inner electrodes 210, 220, 310. For example, the inner insulating layer 130 may be made of a polymer. The forward shockwave catheter 100 further includes an outer extension 120 surrounding the shockwave devices 200, 300. The outer extension 120 is a rigid structure to facilitate insertion and advancement into the blood vessel, and the outer extension 120 can be braided, non-braided, or coiled. For example, the outer extension 120 can be braided to improve mechanical strength and reduce kinking. It is understood that the inner extension 110 and the outer extension 120 can be made of a variety of suitable materials, depending on the required mechanical properties, such as stiffness.

[0140] In some instances, the outer extension 120 is directly attached to the inner extension 110. In some instances, the forward shockwave catheter 100 includes a distal cap 140 connecting the inner extension 110 and the outer extension 120. The distal cap 140 is arranged around the shockwave device 200, 300 and has a tapered portion 142 for guiding a dual shockwave (first and second shockwaves from device 200) or a single shockwave (from device 300) forward, i.e., forward in a generally distant direction. The forward shockwave catheter 100 may also include a distal tip 150 attached to the distal portion of the inner extension 110 and the distal cap 140. The distal tip 150 has a tapered portion 152 to facilitate movement of the shockwave catheter 100 within a blood vessel. It is understood that the distal cap 140 and the distal tip 150 may be made of a variety of suitable materials, depending on the desired mechanical properties, such as stiffness. For example, the distal end cap 140 can be more flexible than the outer extension 120.

[0141] In some instances, shock wave devices 200, 300 include one or more peripheral cavities 270, 370, which may be filled with a conductive fluid. A distal end cap 140 may be configured to contain the conductive fluid to fill the peripheral cavities 270, 370 and spark gaps 242, 244, 340. The distal end cap 140 may be connected to suitable fluid components (e.g., pumps and valves) to circulate the conductive fluid within the distal end cap 140 and within the peripheral cavities 270, 370 and spark gaps 242, 244, 340. Circulation of the conductive fluid prevents the accumulation and stagnation of cavitation bubbles generated by the shock wave devices 200, 300. If these cavitation bubbles become trapped in the distal end cap 140 due to accumulation and stagnation, they will prevent subsequent shock waves from propagating from the devices 200, 300. Furthermore, circulation of the conductive fluid can also help cool the shock wave devices 200, 300.

[0142] As shown in Figures 14 and 15, the forward shockwave catheter 100 can be used to treat diseases and / or perform medical procedures within a patient's conduit system 400, particularly for treating high-resistance lesions 410. The conduit system 400 may include any conduits within the patient's body, such as blood vessels or ureters. High-resistance lesions 410 may include calcified plaque lesions in blood vessels or kidney stones in the ureter. Shock waves propagate forward in a remote direction from the shockwave devices 200, 300 to treat the high-resistance lesion 410 within the conduit system 400.

[0143] In some examples shown in Figure 16, a method 500 is proposed for treating high-resistance lesions 410 (such as calcified plaques) in a blood vessel using a forward shockwave catheter 100 including a dual shockwave device 200. Method 500 includes step 510 of inserting the forward shockwave catheter 100 along a pre-embedded receiving guidewire 160 into a conduit system 400 (here referring to a blood vessel). Method 500 includes step 520 of advancing the forward shockwave catheter 100 forward in a remote direction into the conduit system 400 (here referring to a blood vessel) until the distal portion of the dual shockwave device 200 is opposite the starting segment of the treatment site. Method 500 includes step 530 of applying a high potential difference across conductors 250, 260. Method 500 includes step 540 of generating dual shock waves at a first spark gap 242 and a second spark gap 244 in response to the applied high potential difference. Method 500 includes step 550 of propagating a dual shock wave forward in a remote direction through conductive fluid in spark gaps 242, 244. Method 500 includes step 560 of impacting a high-resistance lesion 410 (such as a calcified plaque) within a blood vessel with the dual shock wave, thereby achieving a therapeutic effect of pulverizing the lesion.

[0144] In some examples shown in Figure 17, a method 600 is proposed for treating high-resistance lesions 410 (such as calcified plaques) using a forward shockwave catheter 100 including a single shockwave device 300. Method 600 includes step 610 of inserting the forward shockwave catheter 100 along a pre-embedded receiving guidewire 160 into a conduit system 400 (here referring to a blood vessel). Method 600 includes step 620 of advancing the forward shockwave catheter 100 forward in a remote direction into the conduit system 400 (here referring to a blood vessel) until the distal portion of the shockwave device 300 is opposite the starting segment of the treatment site. Method 600 includes step 630 of applying a high potential difference across conductors 350, 360. Method 600 includes step 640 of generating a single shockwave at a spark gap 340 in response to the applied high potential difference. Method 600 includes step 650 of propagating the single shockwave forward from the spark gap 340 through conductive fluid in the spark gap 340 in a remote direction. Method 600 includes step 660, which uses a single shock wave to impact a high-resistance lesion 410 (such as a calcified plaque) within a blood vessel, thereby achieving a therapeutic effect of pulverizing the lesion.

[0145] As shown in Figures 14 and 15, a shock wave 700 from the shock wave catheter 100 impacts a high-resistance lesion 410 (such as a calcified plaque) within the blood vessel, creating a fissure 420 within the high-resistance lesion 410 (such as a calcified plaque). The fissure 420 helps to break up and weaken the high-resistance lesion 410 (such as a calcified plaque) within the blood vessel, enabling subsequent expansion of the treatment site using methods such as balloon catheters and stents. It is understood that the shock wave 700 can be repeatedly generated as needed by the clinician to treat high-resistance lesions 410 (such as calcified plaques) within the blood vessel at the treatment site. Methods 500 and 600 may further include the step of advancing the forward shock wave catheter 100 forward in a remote direction into the blood vessel 400 until the shock wave devices 200 and 300 are opposite the next treatment site. Understandably, the steps of methods 500 and 600 can be repeated to advance the shockwave catheter 100 into the conduit system 400 (here referring to a blood vessel) and treat high-resistance lesions 410 (such as calcified plaques) within the blood vessel at one or more treatment sites within the blood vessel.

[0146] Methods 500 and 600 may further include: removing the shockwave catheter from the conduit system 400 (here referring to a blood vessel); inserting a second medical device into the conduit system 400 (here referring to a blood vessel); and advancing the second medical device forward in a distal direction into the conduit system 400 (here referring to a blood vessel) to continue treatment of the high-resistance lesion 410 (such as a calcified plaque) at the treatment site. For example, the second medical device may include a balloon catheter and a stent for treating atherosclerotic lesions at the treatment site.

[0147] More specifically, after treating one or more treatment sites within the conduit system 400 (referring to a blood vessel) for high-resistance lesions 410 (such as calcified plaques), the shockwave catheter 100 is removed from the blood vessel, and a second medical device, such as a balloon catheter, is introduced to continue treatment of the high-resistance lesion 410 (such as calcified plaques). The forward shockwave catheter 100, equipped with shockwave devices 200 and 300, is smaller than a balloon catheter and can be inserted into lesions that are too narrow and rigid due to a significant increase in high-resistance lesions 410 (such as calcified plaques) at the treatment site, making them difficult for balloon catheters to pass through. The forward shockwave catheter 100 can even continue to break up and advance along subsequent long segments of the lesion after breaking through the initial cap-like structure of the high-resistance lesion 410 (such as calcified plaques) along the pre-embedded receiving guidewire 160, ultimately completely breaking through the entire length of the lesion. The forward shockwave 700 is used to initially treat the intravascular high-resistance lesion 410 (such as a calcified plaque), creating a fissure 420 that disrupts and weakens the lesion 410. The forward shockwave catheter 100 is removed, and a balloon catheter or stent is advanced into the body's conduit system 400 (the blood vessel). The weakened intravascular high-resistance lesion 410 (such as a calcified plaque) at the treatment site makes it easier for the subsequent balloon catheter or stent to pass through and dilate and support the treatment site. In some cases, the intravascular high-resistance lesion 410 forms a ring-shaped and rigid calcified ring around the vessel, which the balloon catheter cannot effectively dilate without any initial shockwave treatment. The forward shockwave 700 helps to break through and weaken the calcified ring, allowing the subsequent balloon catheter or stent to treat the weakened calcified ring and dilate and support the lesion site. The subsequent balloon catheter can be a shockwave balloon catheter, which can further treat the weakened calcified ring with omnidirectional shockwave before conventional balloon dilation of the treatment site.

[0148] Therefore, the forward shockwave catheter 100 and methods 500, 600 can be used in medical applications where high-resistance lesions 410 (such as vascular plaques or urinary tract stones) exist in the human conduit system 400, making the conduit system 400 very narrow and rigid, thus making it difficult for a second medical device, such as a larger balloon catheter, to pass through such a conduit system 400 (such as a blood vessel or ureter). The forward shockwave catheter 100 is smaller than a balloon catheter and can more easily pass through tight, high-resistance lesions 410 that are difficult for a balloon catheter to pass through. It is understood that in methods 500, 600, a receiving guidewire 160 is used as part of a standard medical procedure to guide the movement of the forward shockwave catheter 100 within the human conduit system 400 (such as a blood vessel or ureter). It is also understood that various guiding devices, such as imaging devices, can be used to position the forward shockwave catheter 100 at the desired treatment site.

[0149] As described in the various examples herein, the forward shock wave 700 generated by the forward shock wave catheter 100, shock wave device 200, 300, and methods 500, 600 propagates forward in a remote direction to treat the high-resistance lesion 410. The forward-propagating forward shock wave 700 can more effectively target the high-resistance lesion 410 in front of the forward shock wave catheter 100, thereby weakening the high-resistance lesion 410 for treatment by a second medical device.

[0150] In the above detailed description, embodiments of the invention relating to shock wave devices and shock wave ducts including shock wave devices are illustrated with reference to the provided figures. The description of the various embodiments herein is not intended to limit one to specific or particular representations of the invention, but is merely to illustrate non-limiting examples of the invention. The invention aims to address at least one problem and issue associated with the prior art. Although only some embodiments are disclosed herein, it will be apparent to those skilled in the art, upon reading this description, that various changes and / or modifications can be made to the disclosed embodiments without departing from the scope of the invention. Therefore, the scope of the invention, and the scope of the following claims, is not limited to the embodiments described herein.

Claims

1. A shock wave device, characterized in that, include: An inner electrode, the inner electrode being arranged around a longitudinal axis and extending axially along the longitudinal axis; An outer electrode, which is arranged around the inner electrode and radially away from the inner electrode, and extends axially along the longitudinal axis; A first wire, which is electrically connected to the inner electrode and electrically insulated from the outer electrode; The second wire is electrically connected to the outer electrode and electrically insulated from the inner electrode; as well as A spark gap is formed between the uninsulated portion of the inner electrode and the uninsulated portion of the outer electrode; In response to the potential difference applied across the first and second conductors, an arc discharge is generated across the spark gap, causing the arc discharge to generate a single shock wave, which propagates forward from the spark gap through the conductive fluid in the spark gap in a distance direction.

2. The shock wave device according to claim 1, characterized in that, It also includes one or more peripheral cavities located between the inner electrode and the outer electrode, wherein the peripheral cavities may be filled with a conductive fluid.

3. The shock wave device according to claim 1, characterized in that, It also includes an outer insulating layer located between the inner electrode and the outer electrode, which is used to insulate the outer electrode from the first wire and to insulate the inner electrode from the second wire.

4. The shock wave device according to claim 3, wherein, The outer insulation layer includes a polymer, adhesive, or plastic insert.

5. The shock wave device according to claim 1, characterized in that, The uninsulated portion of the outer electrode is formed at the distal end of the outer electrode, and the uninsulated portion of the inner electrode is formed at the distal end of the inner electrode.

6. The shock wave device according to claim 3, characterized in that, The distal portion of the inner electrode is axially misaligned with the distal portion of the outer electrode; or The distal portion of the inner electrode is aligned with the distal portion of the outer electrode.

7. The shock wave device according to claim 1, characterized in that, The uninsulated portions of the inner electrode and the outer electrode include chamfered distal ends.

8. The shock wave device according to claim 1, characterized in that, The inner electrode and the outer electrode include an insulating coating for insulating the outer electrode from the first conductor and for insulating the inner electrode from the second conductor. The insulating coating includes holes that form uninsulated portions of the electrodes and form the spark gap.

9. The shock wave device according to claim 1, characterized in that, The internal electrodes include two, namely a first internal electrode and a second internal electrode, thereby enabling the shock wave device to generate a dual shock wave, i.e. A shock wave device, characterized in that it comprises: A first inner electrode and a second inner electrode are arranged around a longitudinal axis and extend axially along the longitudinal axis, and the first inner electrode and the second inner electrode are offset from each other in the circumferential direction. An outer electrode is arranged around the first inner electrode and the second inner electrode and is radially away from the first inner electrode and the second inner electrode, and extends axially along the longitudinal axis; A first wire, which is electrically connected to the first inner electrode and electrically insulated from the outer electrode; The second wire is electrically connected to the second inner electrode and electrically insulated from the outer electrode; A first spark gap is formed between the uninsulated portion of the first inner electrode and the first uninsulated portion of the outer electrode; and The second spark gap is formed between the uninsulated portion of the second inner electrode and the second uninsulated portion of the outer electrode; In response to the potential difference applied across the first and second conductors, an arc discharge is generated across the first and second spark gaps, causing the arc discharge to generate a double shock wave, which propagates forward from the spark gap through the conductive fluid in the spark gap in a remote direction.

10. The shock wave device according to claim 9, characterized in that, The external electrode includes an insulating coating for insulating the external electrode from the wire. The insulating coating includes a first hole and a second hole, which respectively form the first uninsulated portion and the second uninsulated portion of the external electrode.

11. The shock wave device according to claim 9, characterized in that, It also includes one or more peripheral cavities located between the outer electrode and the inner electrode, wherein the peripheral cavities may be filled with a conductive fluid.

12. The shock wave device according to claim 9, characterized in that, It also includes an outer insulating layer located between the outer electrode and the wire, which is used to insulate the outer electrode from the wire.

13. The shock wave device according to claim 12, characterized in that, The outer insulation layer includes a polymer, adhesive, or plastic insert.

14. The shock wave device according to claim 9, characterized in that, The uninsulated portion of the outer electrode is formed at the distal end of the outer electrode, and the uninsulated portion of each of the inner electrodes is formed at the respective distal end of the inner electrode.

15. The shock wave device according to claim 9, characterized in that, The distal portions of each of the inner electrodes are axially misaligned with the distal portions of the outer electrodes; or The distal portion of each inner electrode is aligned with the respective distal portion of the outer electrode.

16. The shock wave device according to claim 9, characterized in that, The uninsulated portions of the inner electrode and the outer electrode include chamfered distal ends.

17. The shock wave device according to claim 9, characterized in that, Each inner electrode includes an insulating coating, and each insulating coating includes holes forming the uninsulated portion of each inner electrode.

18. A shock waveguide, characterized in that, The shock wave device as described in any one of claims 1-17 further includes an inner extension member and an outer extension member, wherein, The shock wave device is disposed at the distal portion of the shock wave duct and surrounding the inner extension, the inner extension including an inner cavity along a longitudinal axis for receiving a guidewire. The shock wave device is configured to generate a shock wave that propagates forward in a remote direction from the shock wave device.

19. The shock waveguide according to claim 18, characterized in that, It also includes an inner insulating layer located between the inner extension and the inner electrode.

20. The shock waveguide according to claim 18, characterized in that, It also includes a distal end cap that attaches the inner extension and the outer extension together, the distal end cap including a tapered portion for guiding the shock wave forward.

21. The shock waveguide according to claim 20, characterized in that, It also includes a distal tip attached to the distal portion of the distal cap and the inner extension, the distal tip including a tapered portion to facilitate movement of the shock wave catheter in the blood vessel.

22. The shock wave duct according to claim 20, characterized in that, The distal cap is configured to contain the conductive fluid to fill one or more peripheral cavities and the spark gap of the shock wave device.

23. The shock waveguide according to any one of claims 1-22, characterized in that, Follow these steps to use it: When used to treat vascular high-resistance lesions such as calcified plaques, a shockwave catheter is inserted into the patient's blood vessels, the shockwave catheter including the shockwave device described above. The shockwave catheter is advanced forward into the blood vessel in a remote direction until the distal portion of the shockwave device is opposite the proximal (or initiation) portion of the treatment site. A potential difference is applied across the first and second conductors; A shock wave is generated at the spark gap in response to the applied potential difference; The shock wave propagates forward in a distance from the spark gap through the conductive fluid within the spark gap; and The shock wave is used to impact the high-resistance vascular lesion (such as calcified plaque), thereby pulverizing the lesion at the treatment site and treating the vascular plaque or high-resistance lesion.

24. The shock wave duct according to claim 23, characterized in that, The operation also includes the following steps: Remove the shock wave catheter from the blood vessel; Insert the second medical device into the blood vessel; The second medical device is advanced into the blood vessel in a remote direction to continue treatment of vascular plaque or high-resistance lesions at the treatment site.

25. The shock waveguide according to claim 24, characterized in that, The second medical device includes a balloon catheter and a stent, which are used in conjunction with the shockwave catheter of the present invention.

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